Lanreotide as Treatment of Polycystic Livers

Phase 2

Completed

• Conditions: Polycystic Liver Disease; Hepatomegaly; Liver Diseases; Polycystic Kidney, Autosomal Dominant
• Interventions: Drug: Placebo; Drug: Lanreotide

• Registration Number: NCT00565097
• Lead Sponsor: Radboud University Medical Center

Brief Summary

To assess the efficacy of lanreotide in controling total liver volume in patients with polycystic livers this study will be performed. A minimum of 38 patients will be recruited and randomized (1:1) to receive either verum or placebo. Lanreotide is already used in other disease states and found to be safe and non-toxic.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-28
• Study First Posted: 2007-11-29
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-16
• Last Update Posted: 2009-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• 18 yrs-of age
• Multiple cysts > 20
• Cooperating patient
• Is willing and able to comply with the study drug regimen and all other study requirements
• Willingness to give written informed consent

Exclusion Criteria

• Use of oral anticonceptives or estrogen suppletion
• Females who are pregnant or breast-feeding
• History or other evidence of chronic pulmonary disease associated with functional limitation
• History of severe cardiac disease
• History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
• Symptomatic gallstones
• Renal failure requiring hemodialysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Lanreotide	Lanreotide

Primary Outcome Measures

Name	Time	Method
Reduction of total liver volume as determined by CT scan	6 months

Secondary Outcome Measures

Name	Time	Method
Reduction of liver volume and individual cyst volume on CT scan.	6 months
Change of kidney volume and individual cyst volume on CT scan	6 months
Symptom evaluation by (validated) questionnaires	6 months

Trial Locations

Locations (2)

University Hospital Gasthuisberg; 🇧🇪 Leuven, Belgium

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands